Scient’x selects Invibio PEEK-OPTIMA® polymer for interbody fusion cages

Guyancourt, France – French implant manufacturer Scient’x has selected

PEEK-OPTIMA, a high performance biocompatible polymer from Invibio Ltd, for a pioneering range of cervical and lumbar spinal fusion cages. Designed to meet the most rigorous performance criteria, PEEK-OPTIMA is one of the first high performance thermoplastics to be used in long-term in vivo applications such as spine implants. Scient’x is among the first medical device companies to use PEEK-OPTIMA for its extensive product range.

The use of polymers for interbody cages provides two main advantages. First, it improves the bone-implant interface because of an elasticity modulus close to cortical bone, and, secondly, it offers a better post-operative evaluation due to inherent radiolucency. Scient’x polymeric cages are made of pure PEEK-OPTIMA polymer with gold wires embedded in the polymer matrix for radiological verification.

Several materials have been evaluated by Scient’x for interbody cages. The choice of PEEK-OPTIMA polymer follows extensive research into the mechanical, physical and biological properties offered by different polymers and metallic materials.

Biomechanical considerations

Independent tests of the mechanical properties of PEEK-OPTIMA polymer have shown that its elasticity modulus is 3.6 GPa, compared to 0.2 GPa and 15 GPa for spongious and cortical bone respectively, and 110 GPa for titanium alloy Ti-6Al-4V.

According to Wolff's law, bone requires the stimulus of mechanical stress to maintain its structure. Metallic implants sustain far higher stresses than the surrounding bone, resulting in an unfavourable ‘stress shielding’ effect that is widely believed to lead to implant failure. As the elastic properties of

PEEK-OPTIMA polymer can be tailored closer to the bone characteristics than titanium, Scient’x implants made of PEEK-OPTIMA polymer offer a mechanical strength that is far better adjusted to bone ingrowth. The result is a better stress distribution on the surface of the cage. This improves the bone-implant interface and leads to superior bone fusion.

Biocompatibility

PEEK-OPTIMA polymer is supported by extensive certification including FDA Device Master File (MAF) and the Drug Master File (DMF), EEC Directive 90/128/EEC, ISO 10993 compliance including USP Class VI biocompatibility test results and long-term implantation data. Scient’x has backed up the results obtained from scientific literature by complementary biological evaluation tests on cages made using PEEK-OPTIMA polymer. These stringent tests cover cytotoxicity, sensitization, genotoxicity and pyrogenicity and USP XXIII compliance, (US classification of medical grade materials). All tests have demonstrated the biocompatibility of PEEK-OPTIMA polymer.

Sterilization

To ensure that devices are clean and infection-free, today’s sterilization processes incorporate aggressive chemicals, higher pressures in steam autoclave and higher doses of radiation. PEEK-OPTIMA polymer offers maximum in-use flexibility as it can be sterilized using all standard processes, including autoclaving, radiation and gas sterilization.

PEEK-OPTIMA polymer has superior resistance to chemicals, radiation, steam and moisture. Due to its semi-crystalline nature, the material maintains its mechanical and chemical properties after 3,000 hours in high-pressure steam. It has unequalled stability following exposure to radiation and will resist nearly any chemical with the exception of extremely strong oxidizing agents.

Evaluation of results

The radiolucency of PEEK-OPTIMA polymer enables complete post-operative inspection with various techniques such as X-Ray, CT scanning and MRI. Cages made of PEEK-OPTIMA polymer can be shown on X-ray pictures with sharp contrasts through a material modification with suitable fillers. During computer tomography, implants made of PEEK-OPTIMA polymer produce no optical distortion, allowing an accurate view of the vertebral bodies. This makes it easier for the surgeon to recognize and evaluate the quality of the fusion.

Manufacturer

Reader enquiries

Invibio Ltd
Technology Centre
Hillhouse International
Thornton Cleveleys
Lancashire FY5 4QD
United Kingdom
+44 1253 866812
info@​invibio.com
www.invibio.com

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Notes for editors

Invibio™ provides biomaterial solutions for the implantable medical device market. PEEK-OPTIMA polymer is produced at its headquarters and manufacturing facility in the United Kingdom. With offices also in the USA and Europe it is the sole world-wide manufacturer and distributor of PEEK-OPTIMA polymer, an advanced biomaterial suitable for long term implantation.

For more information on the properties and performance advantages of PEEK-OPTIMA polymer, please call +44 (0) 1253 866812 or visit the company’s website at www.invibio.com.

Invibio Ltd is a wholly owned subsidiary of Victrex plc.